postmarketing study to determine performance of the sigma hp® partial knee system

Conditions: Osteoarthritis; Post-traumatic Arthritis; Gout; Pseudo-gout

Summary: this is a postmarketing study to assess the overall performance and survivorship of the sigma hp® partial knee system.

the purpose of this study is to collect more information about the sigma hp® partial knee system made by depuy international. the aim of this study is to measure how this particular type of knee replacement performs over a two year period.

Eligibility criteria:
inclusion criteria: * male or female subjects, aged at least 21 years. * subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. * subjects, who, in the opinion of the clinical investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. * subject has non-inflammatory degenerative joint disease (nidjd), including: osteoarthritis, posttraumatic arthritis, avascular necrosis and chondrocalcinosis. * subject has a functional stable knee. * subject, in the opinion of the investigator, is suitable for either a single or bicompartmental knee replacement. * subject meets the following selected radiographic parameters: * x-ray evaluation confirms the presence of nidjd * disease location: 1 to 2 compartments, maximum. disease can be present in the patellofemoral compartment, the medial tibiofemoral compartment, lateral tibiofemoral compartments alone or in any two compartments. * disease severity: kellgren and lawrence44 grade ii or greater for all compartments replaced. exclusion criteria: * subjects who, in the opinion of the clinical investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation. * women who are pregnant. * subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. * subjects who have participated in a clinical investigation with an investigational product in the last 3 months. * subjects who are currently involved in any injury litigation claims. * multiple joint involvement that will compromise rehabilitation (for example: advanced hip, ankle or spine disease). * known to be a prisoner, mentally incompetent, an alcohol / drug abuser, involved in medical-legal case or worker's compensation * previous knee arthroplasty (any type) in any one of the three compartments of the knee. * requires more than a lateral soft tissue release or an anterior cruciate ligament reconstruction. * uncorrectable anatomical tibio-femoral angle. * bone deficiency requiring structural bone grafts to support the implants. * previous patellectomy. * for subjects indicated for a patellofemoral arthroplasty, subject has uncorrected patella baja (caton-deschamps ratio less than or equal to 0.6). * tri-compartmental disease process (patella-femoral, medial tibio-femoral and lateral tibio-femoral). * active bacterial infection that may spread to other areas of the body (e.g., osteomyelitis, pyogenic infection of knee joint, urinary tract infection, etc.). * significant neurological or musculoskeletal deformity or a disease that may affect gait or weight bearing, (e.g., muscular dystrophy, multiple sclerosis, amputation). * known allergy to implant materials.

Keywords: osteoarthritis knee knee replacement knee implant knee arthroplasty unicompartmental primary partial patellofemoral medial lateral bicompartmental cemented post-traumatic arthritis of the tibio-femoral and/or patellofemoral articular surfaces history of gout or pseudo-gout.